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Study of IMG-007 injection to treat moderate to severe atopic dermatitis in adults

Fast replyInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on testing a new medication called IMG-007 for people who have moderate-to-severe atopic dermatitis, which is a chronic skin condition causing red, itchy, and inflamed skin. The medication is given as a subcutaneous injection under the skin.

The purpose of this research is to evaluate how well different doses of IMG-007 work compared to placebo in treating atopic dermatitis. The study will examine if the medication can reduce the severity and extent of skin symptoms in adults with this condition. The medication will be tested over a period of 20 weeks to determine its effectiveness and safety.

During the study, participants will receive either IMG-007 or placebo through injections under the skin. The study is designed as a double-blinded trial, which means neither the participants nor the doctors conducting the study will know who receives the actual medication and who receives the placebo. Participants will be allowed to continue using regular moisturizers throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your participation begins with confirming that you have had atopic dermatitis for at least 1 year
A healthcare professional will assess if your condition qualifies as moderate-to-severe atopic dermatitis
You must be between 18 and 74 years old to participate
Step 2
Treatment preparation
You will need to use a regular, non-medicated moisturizer throughout the study
Previous topical treatments must be discontinued
You will receive instructions about the subcutaneous injection (injection under the skin) procedure
Step 3
Treatment phase
You will receive either IMG-007 or a placebo through subcutaneous injection
The treatment period lasts for 20 weeks
Neither you nor your doctor will know whether you are receiving IMG-007 or placebo
Regular assessments of your skin condition will be conducted using the Eczema Area and Severity Index (EASI)
Step 4
Monitoring
Your skin condition will be evaluated at week 16 and week 20
Healthcare professionals will monitor any side effects throughout the study
The severity of your atopic dermatitis will be regularly assessed
You must report any changes in your health during the study period
Step 5
Safety requirements
Female participants must not be pregnant or breastfeeding
Both male and female participants must use effective contraception methods during the study
Regular safety assessments will be conducted throughout the study period

Who can join the trial?

9 criteria

Age between 18 and 75 years old, both men and women can participate
Must be able to follow study procedures and provide written consent to participate
Must have Atopic Dermatitis (a chronic skin condition causing itchy, inflamed skin) diagnosed for at least 1 year
Must have active moderate-to-severe Atopic Dermatitis
Must have previously used topical treatments (medicines applied to the skin) such as:
- Topical corticosteroids (anti-inflammatory creams or ointments) or
- Topical calcineurin inhibitors (medicines that help control inflammation)
- Must agree to use a regular non-medicated moisturizer
- For women who can become pregnant: must not be pregnant or breastfeeding and must use reliable birth control, or be unable to have children
- For men: must use reliable birth control or be surgically sterilized

Who cannot join the trial?

14 criteria

Age below 18 years or above 65 years
History of serious allergic reactions or anaphylaxis (severe, potentially life-threatening allergic reaction)
Active skin infection requiring treatment
Current diagnosis of skin cancer or pre-cancerous skin conditions
Pregnancy or breastfeeding
Use of systemic medications for atopic dermatitis (medications taken by mouth or injection that affect the whole body) within 4 weeks before study start
Participation in another clinical trial within the past 30 days
Significant medical conditions that could interfere with study participation, including:
- Severe heart disease
- Uncontrolled high blood pressure
- Severe kidney or liver problems
- Active cancer
- History of substance abuse within the past year
- Mental health conditions that could affect ability to follow study procedures
- Known allergies to any of the study medication components

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Responsive
Semmelweis University
Budapest, Hungary
Verified
Synexus Polska Sp. z o.o.
Poznan, Poland

Trial locations

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Investigated drugs

Based on the provided trial data, there is only one active medication involved in the trial: IMG-007 is an investigational drug being studied for treating moderate to severe atopic dermatitis (a type of eczema). This medication is being tested to see how well it can reduce the severity and affected areas of eczema in adult patients. It is being compared to placebo to determine its effectiveness in controlling disease activity and improving symptoms of atopic dermatitis.

Img-007

What is already known about the treatment

IMG-007 – An investigational medication currently undergoing Phase 2b clinical trials for the treatment of moderate-to-severe atopic dermatitis, a chronic inflammatory skin condition. While the specific method of administration is not detailed in the source data, this experimental drug is being studied to evaluate its efficacy in reducing disease activity as measured by the Eczema Area and Severity Index (EASI). The trial is designed as a multicenter, randomized, double-blinded, placebo-controlled study to determine optimal dosing and safety profile. As this is a medication in clinical development, its complete mechanism of action and pharmacological classification are not yet publicly disclosed.

Investigated diseases

Atopic Dermatitis - A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically begins in early childhood but can occur at any age, often appearing in patches on the face, hands, feet, and behind the knees and elbows. Atopic dermatitis follows a pattern of flare-ups and remissions, where symptoms can worsen for a period and then improve. The condition makes the skin barrier more sensitive and less able to retain moisture, leading to dry and easily irritated skin. Environmental factors, stress, and allergens can trigger flare-ups of the condition.